Vapocoolant device

ABSTRACT

The present disclosure discloses and describes a vapocoolant dispenser. Specifically, the dispenser comprises a housing and container of vapocoolant, the dispenser configured to receive a sterilizable dose of high energy radiation and to provide a sterile, hermetically sealed vapocoolant dispenser.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. application Ser. No.17/826,679, filed May 27, 2022, which is a continuation of U.S.application Ser. No. 17/295,350, filed May 19, 2021, which is a 35U.S.C. § 371 National Stage Application of International Application No.PCT/US20/59475, filed Nov. 6, 2020, which claims the benefit of U.S.Provisional Application No. 62/932,144 filed on Nov. 7, 2019, theentirety of each of which is incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to a vapocoolant dispenser suitable forsterilization. Specifically, the vapocoolant dispenser comprises ahousing, the housing comprising a vapocoolant container, the housing andvapocoolant container configured for release of sterilized vapocoolant.

BACKGROUND

Injections are employed millions of times daily all over the world todeliver medicines into people as well as animals. Many times, injectionsare made in areas of the body that are sensitive to pain as the needleis inserted. Cooling of the skin in the vicinity of injection site usingvapocoolant is known to reduce pain, but existing dispensing techniquesand devices can be cumbersome to employ, may cause injury to theinjection site, and employ flammable or environmentally unfriendlymaterials. Recently, products designed for dispensing vapocoolants havebeen found to contain or be contaminated with microorganisms, leading torecalls and other issues.

SUMMARY

In a first example, a sterilizable vapocoolant dispenser is provided.The sterilizable vapocoolant dispenser comprising: a containercomprising vapocoolant, the container having a valve member configuredto release the vapocoolant; a housing having a distal open end; aproximal open end sized to receive a majority portion of the containerand exposing the remainder portion of the container, and; a bottom coversealing the proximal open end and the remainder portion of thecontainer; a lid sealing the distal open end, the lid coupled to thevalve member; and a nozzle receiving member positioned in the housingand configured to engage the valve member for releasing the vapocoolant.In one aspect, the container and its contents are configured forsterilization by high energy radiation.

In another aspect, the housing has an inward and outward tapered portionbetween the distal open end and the proximal open end for receivingfingers of a human hand.

In another aspect, alone or in combination with any of the previousaspects, the container is fixedly positioned in the housing. In anotheraspect, alone or in combination with any of the previous aspects, thelid is irreversibly sealed to the distal open end. In another aspect,alone or in combination with any of the previous aspects, the bottomcover is releasably coupled to the proximal open end.

In another example, a sterilized vapocoolant dispenser is provided. Thesterilized vapocoolant dispenser comprising: a container comprisingsterilized vapocoolant, the container having a valve member configuredto release the vapocoolant; a housing having a distal open end; aproximal open end sized to receive a majority portion of the containerand exposing the remainder portion of the container, and; a bottom coversealing the proximal open end and the remainder portion of thecontainer; a lid sealing the distal open end, the lid coupled to thevalve member; and a nozzle receiving member positioned in the housingand configured to engage the valve member for releasing the vapocoolant.In one example, the container and vapocoolant are configured to remainsterilized until used.

In another aspect, alone or in combination with any of the previousaspects, the container is fixedly positioned in the housing. In anotheraspect, alone or in combination with any of the previous aspects, thelid is irreversibly sealed to the distal open end. In another aspect,alone or in combination with any of the previous aspects, the bottomcover is releasably coupled to the proximal open end.

In yet another example, a method of manufacturing a sterilizedvapocoolant dispenser is provided, the method comprising: introducing acontainer containing vapocoolant to a housing, the housing comprising adistal open end, a proximal open end sized to receive a majority portionof the container and exposing the remainder portion of the container,and; hermetically sealing the proximal open end and the remainderportion of the container with a releasably sealed bottom cover; sealingthe distal open end with a irreversibly sealed lid; and sterilizing thevapocoolant and housing simultaneously using high energy radiation.

These and other objects, aspects and features of the present disclosurewill be better understood from the following detailed description of thepreferred embodiment when read in conjunction with the appended drawingfigures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a dispenser according to the present disclosure.

FIG. 1B illustrates an alternate dispenser according to the presentdisclosure.

FIG. 2A illustrates an exploded view of the dispenser of FIG. 1Aaccording to the present disclosure.

FIG. 2B illustrates an exploded view of the dispenser of FIG. 1Baccording to the present disclosure.

FIG. 3A illustrates a front view of the dispenser of the dispenser ofFIG. 1B.

FIG. 3B is a sectional view taken along line 3B-3B of the dispenser ofFIG. 3A.

FIG. 3C is an enlarged view of section 3C of FIG. 3B.

FIG. 4A illustrates a side view of the dispenser of the dispenser ofFIG. 1B.

FIG. 4B is a sectional view taken along line 4B-4B of the dispenser ofFIG. 4A.

FIG. 5 is a bottom perspective view of the dispenser of FIG. 1B.

FIG. 6 is a top perspective view of the dispenser of FIG. 1B.

FIG. 7A is a top plan view of the housing of the dispenser of FIG. 6 .

FIG. 7B is an enlarged view of section 7B of FIG. 7A.

FIG. 8A is a section view of the dispenser of FIG. 6 .

FIG. 8B is an enlarged view of section 8B of FIG. 8A.

FIG. 8C is an enlarged view of section 8C of FIG. 8A.

FIG. 9A is a bottom plan view of the housing of the dispenser of FIG. 6.

FIG. 9B is an enlarged view of section 9B of FIG. 9A.

FIG. 10 is a perspective bottom view of an alternate housing of thedispenser device disclosed and described herein.

FIGS. 11A and 11B are top and bottom perspective views, respectively, ofa bottom cover of the dispenser disclosed and described herein.

FIG. 11C is a bottom plan view of the cover of FIG. 11A.

FIG. 11D is a section view along section line 11D-11D of FIG. 11C.

FIG. 11E is an enlarged view of section 11E of FIG. 11C.

FIG. 11F is an enlarged view of section 11F of FIG. 11D

FIG. 12A is a partial cutaway perspective side view of the dispenser ofFIG. 1A.

FIG. 12B is an enlarged view of section 12B of FIG. 12A.

FIG. 13A is a top perspective view of the bottom cover of the dispenserdisclosed and described herein.

FIG. 13B is a bottom perspective view of the bottom cover of thedispenser disclosed and described herein.

FIG. 13C is a top plan view of the bottom cover of the dispenserdisclosed and described herein.

FIG. 13D is a section view along section line 13D-13D of FIG. 13C.

FIG. 14 is perspective view of the dispenser of the inventionillustrating an exemplary use of the device as disclosed and describedherein.

FIG. 15 is a flowchart depicting an assembly process of the dispenser asdisclosed and described herein.

DETAILED DESCRIPTION

To address the technical problem of vapocoolant dispensing devicessuffering from the delirious effects of microorganism contamination, thepresent disclosure provides a technical solution that provides asterilizable and/or sterile vapocoolant dispenser and methods ofmanufacturing same. As disclosed herein, the dispenser is configured tohermetically receive and contain a vapocoolant container, be subject tohigh-energy radiation sterilization, and provide for dispensing ofsterile vapocoolant. The dispenser disclosed herein is also configuredfor single use. The presently disclosed dispenser is designed tomaintain a sterile fluid pathway until used. The presently discloseddispenser does not require packaging in a sterile pouch or any othersystem designed to keep the entire device sterile, although, it isoptionally configured to be packaged in such a manner.

As used in this disclosure, the term “sterile” is understood to mean,for example, a medical device that is free of viable microorganisms asdetermined by International standards that specify requirementsincluding validation and routine control of sterilization processes, andrequire, when it is necessary to supply a sterile medical device, thatadventitious microbiological contamination of a medical device prior tosterilization be minimized and/or reduced to a level as prescribed byone or more of the validation standards set by the InternationalStandards Organization (ISO). Whereas, medical devices produced understandard manufacturing conditions in accordance with the requirementsfor quality management systems (see, for example, ISO 13485) may, priorto sterilization, have microorganisms on them, albeit in low numbers,such products are non-sterile. Thus, “sterile” as used herein is theresult of sterilization sufficient to inactivate microbiologicalcontaminants and thereby transform the non-sterile product into sterileproduct in accordance with the one or more ISO validation standards.

As used in this disclosure, the term “sterilizable” is understood tomean an article's or chemical's ability to substantially retain itschemical and physical properties and minimization or absence oftransformations to or production of radiation-induced reaction productsafter receiving a sterilizable high energy radiation dose, such abilitybeing maintained for period of time after receiving the high energyradiation dose. For example, a vapocoolant, after receiving asterilizable high energy radiation dose would substantially orcompletely retain its chemical and physical properties with acceptablylow or undetectable levels of radiation-induced reaction products for atleast 6 months after receiving the high energy radiation dose. Likewise,a dispenser configured to hermetically seal a vapocoolant and itsassociated container, after receiving a sterilizable high energyradiation dose would substantially or completely retain its chemical andphysical properties and provide for the maintaining of stability of thevapocoolant, for at least 6 months after exposure to the high energyradiation dose.

As used in this disclosure, the term “hermetically” is understood tomean completely sealed, so as to prevent or significantly reduce theescape or entry of air, moisture, microorganisms and other contaminationdirectly or indirectly affecting sterility.

In one aspect, the present devices are intended for providing topicalapplication of a vapocoolant to skin. By skin, it is intended to includethe dermis and epidermis, intact mucous membranes, the oral cavity,nasal passageways and the lips. In one aspect, the present device isintended to provide pain management associated with injections, e.g.,pre-injection anesthesia, including but not limited to venipuncture, IVstarts, minor surgical procedures, vaccinations, pediatric care, and thetemporary relief of pain from injuries, e.g., topical anesthesia, suchas sprains, bruising, cuts, abrasions, and insect bites. The presentdevice can also provide myofacial pain management. The dispenser can beconfigured to dispense other compositions, such as medicaments,dissolved or dispensed or distributed in such vapocoolants (e.g., lowboiling solvents), such as ether or fluorocarbons, for non-invasiveperoral (through the mouth), topical (skin), transmucosal (nasal,buccal/sublingual, vaginal, ocular and rectal) and inhalation dispensingto infants or adults. Other compositions that can be dispensed by thepresent dispenser can include removable or indelible inks, e.g., fortattooing or otherwise marking skin with indicia, e.g., phosphorescentinks.

Exemplary examples and discussions that now follow recite the use of avapocoolant to describe manner and method of the presently discloseddispenser. When the dispenser is employed with a vapocoolant, e.g., as a“vapocoolant dispenser,” vapocoolant is released and caused to contactthe skin, producing a rapid cooling effect upon contact. In one aspect,the dispenser is configured to provide the vapocoolant in the form of anaerosol, in either a mist or stream spray. Upon contact with the skin ormucosal membranes, the dispensed vapocoolant evaporates rapidly due tothe low boiling point of the vapocoolant and the relatively hightemperature associated with skin, causing a rapid cooling effect at theapplication site by the evaporation of the vapocoolant.

The container configured for containing the vapocoolant can be comprisedof any material suitable for containing vapocoolant, which typicallyinvolves pressure slightly above that of atmospheric. Suitable materialsinclude metals such as stainless steel and aluminum, plastics,reinforced plastics, glass, and ceramics.

In one portion of the housing one or more suitable structures areprovided that receives the container and its associated valve member andrenders the valve member substantially stationary in a first state.Longitudinal traversal of the container (along the longitudinal axis ofthe dispenser housing) causes the valve member to open so as to affectdispensing of the vapocoolant from within the container and to exit fromthe dispenser. The dispenser of the present disclosure is intended, inone variation, to be provided in a sterile condition or state and usedcontinuously until the container is depleted of vapocoolant and thendiscarded. The device may be used multiple times and, even, on multiplepatients. Of course, the device may be used solely with a single patientand discarded after such use.

The housing can be made of metal, glass, or ceramic. In one aspect, thehousing and any or all of its components can be made of plastic, e.g.,by any desired method including injection molding, compression molding,rotational molding, 3-D printing, and the like. The container can be ofany material suitable for a vapocoolant, e.g., a plastic, metal, glass,or ceramic material capable of containing a liquid and/or gas at apressure above atmospheric. The container can be sized to hold 0.1-1000mL of vapocoolant. In one aspect, the container is sized to containabout 3.5 fl. oz. (103.5 mL). In other aspects, the container is sizedto hold 0.5 mL, 1 mL, 2 mL, 5 mL, 10 mL, 25 mL, 50 mL, 75 mL, 200 mL,500 mL, or 750 mL or more of vapocoolant.

The vapocoolant can be any liquid or combination of liquids havingproperties suitable for use as a vapocoolant. Such properties wouldinclude, low toxicity, low flammability and low combustibility, and/orincludes materials having suitable boiling point and vapor pressure attypical or envisioned end-use temperature/pressure conditions. In oneaspect, one or more halogenated hydrocarbons can be used asvapocoolants. In other aspects, suitable vapocoolants include one ormore refrigerants as defined by American Society of Heating,Refrigerating and Air Conditioning Engineers (ASHRAE) ashydrochlorofluoroolefin, hydrochloric carbon hydrochloroolefin,hydrocarbon, hydroolefin, perfluorocarbon, perfluroolefin,perchlorocarbon, perchloroolefin, or mixtures thereof, for example,1,1,1,3,3-pentafluoropropane, and 1,1,1,2-tetrafluoroethane mixture. Oneor more chemical compounds, e.g., medicaments, can be at least partiallydispersed or dispensed or dissolved in the vapocoolant. In one aspect,the contents of the container, without pressurized air or inert gas,provides its own head-space pressure of above ambient atmosphericpressure, e.g., 1.01 to about 3 atmospheres at ambient temperature. Forexample, 1-3 atmospheres of pressure (about 15 psi to about 45 psi) isachievable by one or more vapocoolants or combinations of one or morevapocoolants and one or more hydrofluorocarbon alkanes (HFA), which canbe safely contained in the container of the present disclosure. Thishead-space pressure without pressurized air or other gas is obtainable,for example, by providing a 95% mixture of a vapocoolant and a 5%mixture of a HFA, e.g., 95 wt. % of 1,1,1,3,3-Pentafluoropropane and 5wt. % of 1,1,1,2-Tetrafluoroethane. Other combinations are possible toachieve the head-space pressure and encompassed by the presentdisclosure. Vapocoolants can include, without limitation, one or morenon-halogen containing low boiling fluids suitable for topical skinapplication, provided that the non-halogen containing the fluid iscapable of operating as a self-propellant by providing a suitablepressure for discharge in a vapor space above the liquid supply of thevapocoolant.

With reference to FIGS. 1A-1B, and exploded views 2A, 2B an embodimentof a dispenser is generally designated by the reference numeral 100 a,100 b (hereinafter collectively also referred to by callout 100),depicted as having an elongated housing 101 a, 101 b, (hereinaftercollectively also referred to by callout 101). In one aspect, thehousing 101 is generally cylindrical. Housing 101 comprises shoulder 102and adjacent taper portion 103 having an inward/outward taper inproximity to a distal end, a dispensing end 104 with lid 105 adjacent tothe distal end, the dispensing end 104 and lid 105 configured forcoupling together. Taper 103 is configured to allow for comfortable andsecure interaction with of a pair of human digits, for example the indexand ring finger, and thus, can provide for one-handed operation whencoupled with the thumb as described herein.

Proximal end of housing 101 includes a bottom cover 106 configured forcoupling with housing 101 and designed with a sealing interface topreserve fluid path sterility. Removable pull-tab 108 is reversiblysealed to lid 105 and hermetically covers opening 107 and vent holes 129preventing contamination and preserving fluid path sterility. Pull-tab108 covering also preserves the sterility of all area inside of the sealto lid 105, ensuring that surfaces proximate to the spray opening 107remain sterile until use. Pull tab 108 may be Tyvek. Thus, the fluidpath sterility for the dispenser 100 is preserved during shipping and upto the point of use with a combination of the bottom cover 106, and theair permeable, sterile barrier pull tab 108.

Proximal end of housing 101 receives a majority of vapocoolant container120 that contains, e.g., vapocoolant. A remainder portion 175 (FIG. 14 )of the container 120 extends from the housing 101. Container 120includes shoulder 130 adjacent tapered neck adjacent distal end 131 withnozzle 132 projecting therefrom. In one example, the contents of thecontainer 120 are under pressure such that the pressure inside of thecontainer 120 is greater than the ambient pressure. Alternate dispenser100 b includes optional projections from the distal end and/ordispensing end 104 so as to present an appealing, friendly, animal-likeappearance, for example, a “teddy bear” with a pair of ears 110 and nose112 for use in pediatrics.

Tamper evident seal 118 with extensions 119 drape over the side of cover106 potentially preventing contamination associated with dislodgement ofcover 106 and can also provide for a visual indication of sterility forthe end user. An optional cylindrical label 117 is sized to surroundcircumference of housing 101 in some embodiments providing additionalsecurity to tamper evident seal extensions 119 by additionally affixingthe seal extensions 119 to housing 101. In one example, label 117comprises artwork or other indicia complimenting optional projections110 and 112. In yet other example, label 117 comprises an integratedbandage or a sticker for use with pediatric patients.

In one example, the combination of tamper evident seal 118 and cover 106functions cooperatively to retain the container in the housing andisolates the interior of the housing from the ambient environment, thusimproving and/or maintaining sterility after sterilization of thedispenser 100. Because nozzle 132 of container 120 may or may not sealcompletely with the channel 135 b of the housing 101, entrapped airwithin the housing of the device can vent through the existing opening107 in the absence of hermetic seal of pull tab 108. In one example, inorder to keep the fluid path of the vapocoolant sterile within thedispenser until use, the presently disclosed dispenser 100 implementsimproved design elements. In one example, the vapocoolant is keptsterile, as well as all surfaces on the vapocoolant container 120, allinternal surfaces of the housing 101, internal surfaces of bottom cover106, and the region bounded by the pull tab 108 and lid 105, e.g., pulltab 108 creates a peelable, hermetic seal. The bottom cover 106 createsa microbial barrier with housing 101, by creating an annual hermeticseal between the bottom cover 106 and the body of the housing 101. In analternative design, housing 101-bottom cover 106 microbial barrier canbe configured to include a tortuous path, rather than a hermetic seal.

In one example, dispenser 100, pull tab 108 and lid 105 utilizes abreathable, sterile barrier material (e.g., Tyvek), which in addition topreventing the ingress of microbial contaminants, permits the interiorof the device to remain at ambient pressure through vent holes 129, andprevents changes in barometric pressure or temperature, e.g., frompopping off the bottom cover 106, due to the breathability of pull tab108. In another example, pull tab 108 could be replaced with anotherelement such as a cap or non-breathable element.

In the presently disclosed dispenser 100, two design configurations arepossible to maintain the sterile fluid pathway of the system. In a firstexample, either or both of the pull tab 108-lid 105 mating junction orbottom cover 106-housing 101 mating junction are configured to provide asterile barrier and/or provide a tortuous path. In a second both thepull tab 108-lid 105 mating junction and bottom cover 106-housing 101mating junction are hermetically and non-breathably sealed but areotherwise capable of preventing changes in pressure from rupturing thehermetic seal.

The presently disclosed dispenser 100 in one example is configured sothat the pull tab 108-lid 105 and bottom cover 106-housing 101configuration both essentially provide sterile barrier junctions so asto maintain sterility of dispenser 100, e.g., even if the dispenser arecarried around in pockets of clinicians, etc., prior to use.

FIGS. 3A and 4A depict orthogonal views of the dispenser 100, with FIGS.3B and 4B providing corresponding section views along section line 3B-3Band 4B-4B, respectively. Housing 101 includes nozzle receiving members133 with channel 135 b essentially centered along the longitudinal axis3B-3B of the housing 101. As shown in FIG. 3C, depicting enlarged viewof section 3C of FIG. 3B, nozzle receiving members 133 includes shoulder137 configured for engaging nozzle 132 of container 120 in a first stateprior to activation/release of vapocoolant via opening 232 of valvemember 136 and aligns distal conduit 135 a of nozzle 132 with channel135 b of housing. Channel 135 b fluidically couples with opening 107 oflid 105. Distal conduit 135 a is cooperatively engaged with valve member136 which is held under the pressure of the contents of container 120 ina closed position in the first state prior to activation. Valve member136 can be a press-down valve or other suitable valve for releasingpressurized contents.

Displacement of valve member 136 along longitudinal axis 3B-3B in asecond state or activation state, allows pressurized contents ofcontainer 120 to enter channel 135 for release through opening 107.Projections 124 from inner surface of housing 101 are positioned betweenshoulder 130 and distal end 131 of container 120 securing container inhousing when support afforded by bottom cover 106 is removed. Interiorof housing 101 adjacent to taper 103 provides for a predeterminedreversible longitudinal travel distance of the distal end 131 ofcontainer 120 within the housing 101 during transition from the firststate to the activation state sufficient for displacement of valvemember 136 and the release of vapocoolant.

Inner diameter of lid 105 is sized for receiving by housing 101 andprovides for hermetic sealing, for example, by ultrasonic, sonicwelding, or adhesive, such that lid 105 forms an airtight, sterile sealwith housing 101. Inner surface of housing 101 includes inwardlyprojecting protrusions 123 which prevent unintentional longitudinalmovement of container 120 within housing towards bottom cover 106 whilein the first state.

Bottom cover 106 has annular ring 174 configured to be received by theannular region 101 c of housing 101. The annular ring 174 and annularregion 101 a can be sized for an interference fit which provides asterile barrier seal. Additional sealing elements can be employed, suchas o-rings or sealing compounds. The housing 101 may also employ lockingfeatures 125 that engage below the annular ring 174 to provideadditional securement for the bottom cover 106. Bottom cover 106 caninclude inwardly projecting protrusion 173 to securely positioncontainer 120 in the interior of housing 101 and maintain alignment orfitment of nozzle receiving members 133 with nozzle 132.

FIGS. 5 and 6 depict perspective bottom and top views, respectively, ofthe housing 101 with the container 120, bottom cover 106, and lid 105removed. Interior inner surface 122 of housing 101 includes a pluralityof spaced-apart longitudinally-extending projections 123 which canfunction to guide container 120 upon assembly to prevent discharge ofcontainer 120. Additionally, inwardly tapered extending projections 123can provide a predetermined resistance of longitudinal motion of thecontainer 120 and the subsequent activation of valve member 136 by theuser. Longitudinally extending projections 123 can vary in extensioninto the interior of housing 101, for example, a longitudinal taper.

Distal portion 104 encircles projecting annular platform 140 terminatingin dispensing assembly 141. Annular ring 143 of dispensing assembly 141encircles post 114. Annular ring 143 includes a plurality of spacedapart cutouts 142 on exposed surface of annular ring 143.

FIGS. 7A and 7B depict a top plan view of distal portion 104 an enlargedview of dispensing assembly 141. FIGS. 8A, 8B, and 8C provide asectional view and enlarged views of dispensing assembly 141. As shown,opening 145 fluidically coupled to conduit 134 partially encircles post114 and provides for a fluidic path of the contents of container 120 ofdispenser 100 when in the activated state.

FIGS. 9A and 9B depict a bottom plan view of housing and enlargedsection 9B of FIG. 9A showing nozzle receiving member 133, post 114, andopening 145. FIG. 10 depicts an alternate embodiment of housing 101whereby nozzle receiving members 133 is radiantly supported by aplurality of supporting walls 127.

FIGS. 11A and 11B depict top and bottom perspective views of lid 105.FIG. 11C depicts a plan view of the underside of lid 105. FIG. 11D is asectional view along line 11D-11D. FIG. 11E is an enlarged view ofsection 11E of FIG. 11D, and FIG. 11F is an enlarged view of section 11Fof FIG. 11E. Lid 105 includes reduced diameter annular ring 105 a sizedto encircle annular platform 140, for example in an interference fitrelationship or may loosely fit for subsequent ultrasonic welding. Topsurface of lid includes vent holes 129 surrounding opening 107. Ventholes 129 provide a pathway for pressure equalization of the internalvolume of the housing, preventing pressure build up and dislodgment ofbottom cover 106 and pull tab 108 preserving the sterile fluid path.Vent holes may also provide for outgassing during sterilization usinghigh-energy radiation such as x-rays, gamma rays, or electron-beam aswell as maintaining pressure equilibrium during transportation/storageand temperature changes. Pull tab 108 is made of an air permeablesterile barrier material (e.g. Tyvek) and is continuously sealed aroundvent holes 129 and opening 107. Interior surface of lid 105 includesprojecting annular wheel 138 and annular protrusion 165 providing twoannular welds when joined to the distal portion 104 of housing 101.Annular wheel 138 encircles annular protrusion 165 sized to encirclepost 114. Raised platform 162 having projecting posts defines channels163 when lid 105 is joined to the housing 101 and brought in contactwith the distal surface of post 114, a dispenser “spray nozzle” isformed, providing for efficient diffusion of escaping contents ofcontainer 120 and working cooperatively with opening 145 for efficientand even dispensing of vapocoolant. In one example, the aforementionedcomponents of lid 105 comprise a micromist assembly configured to splitthe flow of the vapocoolant upon release from the container 120 so thatone or more flows of vapocoolant can recombine in and/or interact withone or more components of lid 105 so as to provide a vortex that aids inmaking a finer mist of vapocoolant.

FIG. 12A depicts a partial section view of the housing 101 and lid 105joining. FIG. 12B is an enlarged view of section 12B of FIG. 12A showingvarious ultrasonic welding spots 155 a, 155 b complementarily positionedamong lid 105 and distal portion 104 of housing 101 for hermeticallysealing lid 105 to distal portion 104 of housing 101. Welds 155 a, 155 bprovide for the formation of a space above annular ring 143 on housing101 and the inside of lid 105, the space fluidly communicates with thevent holes 129 and vent holes 144 of housing 101, allowing the interiorof the dispenser to vent to the outside environment through the sterilebarrier pull tab 108 that is sealed around the vent holes 129 on theexternal surface of lid 105.

FIG. 13A depicts a perspective view of bottom cover 106 having ergonomicfeatures 172 for assisting in removing cover from housing 101. Bottomcover 106 includes smaller diameter annular ring 174 for engagingannular region 101 a. FIG. 13B depicts a perspective view of bottomcover 106 showing surface 171. FIG. 13C depicts a top plan view of innersurface of the bottom cover 106 showing protrusion 173. FIG. 13D is asection view along section line 13D-13D of FIG. 13C. In one variation,the container 120 is not refillable and dispenser 100 is intended forsingle use. In another example, dispenser 100 is configured to be usedat least once or until depleted of contents, the dispenser 100 wouldthen be disposable.

With the various embodiments having been described in detail above, amethod of operation will now be explained. Container 120 has vapocoolantcontained therein by valve member 136, e.g., tilt-valve, press-valve,with nozzle 132 received by a plurality of nozzle receiving members 133,which is shown as three members integral with housing 101. The fixedrelationship between the interval nozzle receiving members 133 of thehousing and the nozzle 132 of valve member 136 provides, in a firststate, a sealed relationship of the container and allows transition to asecond state where the nozzle 132 of container 120 is urged towards thenozzle receiving members 133 of the housing (via linear translation ofthe container into the housing along the longitudinal axis housing bythe user's thumb, for example) causing the nozzle 132 to engage thenozzle receiving members 133 allowing release of the vapocoolantessentially parallel with the longitudinal axis of housing 101. Thisguides the escaping vapocoolant perpendicularly towards raised platform162 and channels 163 and ultimately exiting via opening 145. When theuser releases the force on the container, the valve member 136, alone orin combination with inwardly projecting protrusions 123, provides arestoring force to translate the container in the opposite direction,disengaging the nozzle 132 from nozzle receiving member and back to thefirst state while also discontinuing dispensing of the vapocoolant.

In one aspect, peel away tamper evident seal 118 and tab 108 is removed.Alternatively, the entire bottom cover assembly 106 can be removedtogether with tamper evident seal 118. With bottom cover 106 removed,portion of container 120 is exposed from housing 101. In one example, asshown, a user may grasp the tapered portion of housing 101 between indexfinger 302 and ring finger 303 and position thumb 301 against container120. Exerting a force on container 120 using thumb 301 translatescontainer longitudinally within housing 101 and places device and anactivated state whereby valve member 136 is actuated releasing thecontents 305 of container 120 through opening 107 thus, the presentdispenser 100 avoids needing a “second hand” and the need to putdispenser 100 down so as to access and use another device. In oneexample, a user may grasp the tapered portion of housing 101 betweenindex finger 302 and ring finger 303 and position thumb 301 againstcontainer 120 so as to use the dispenser 100 in a one-handed, “pen-like”or “air-brush-like” manner.

Referring to FIG. 15 , a packaging method providing for aseptic orsemi-aseptic assembly is depicted by flowchart 700. Step 705 includescontainer 120 and valve member 136 assembly and vapocoolant filling step710. Independently, or concurrently, housing components, typically viainjection molding or other thermoplastic molding technique are used toconstruct housing 101, lid 105, and bottom cover 106 as depicted in step715. Step 720 brings housing 101 and container 120 together for deviceassembly. Step 720 can be performed in a sterile environment, clean roomenvironment, or under other aseptic or semi-aseptic conditions andincludes, for example, lid 105 welding to housing 101, heat sealing ofpull tab 108 to lid 105, introducing container 120 to housing 101, andpress attachment of bottom cover 106 to housing. Likewise, step 725involves applying the tamper seal and/or optional labeling. Step 730involves dispenser 100 sterilization using high energy radiation so asto sterilize the vapocoolant contents of container 120 as well asdispenser 100. Step 735 involves packaging of the nonsterile andhermetically sealed dispenser 100.

In one aspect, the dispenser 100 can be configured to releasevapocoolant for a time of approximately 1 to 10 seconds, or longer. Inone aspect the dispenser is configured to release vapocoolant for 1-2seconds, 3 to 5 seconds, 6-10 seconds, or longer. In other aspects, thedispenser 100 is configured to release vapocoolant continuously.

Either while the vapocoolant is flowing or just after the flow of thevapocoolant is stopped, the skin can then be accessed e.g., penetratedby a needle of the syringe to a desired depth, insertion of catheter orother medical device or the like. In using the dispenser 100 disclosed,various types of dermal/sub-dermal accesses may be subsequentlyemployed, such as subcutaneous, intramuscular or intradermal.

If desired, additional injections may be carried out at the same or atdifferent locations. During the process of injection multiple injectionsat the same or different sites, additional vapocoolant may be dispensedas desired to provide or maintain the numbness of the skin at thatlocation. In one example, dispenser 100 can be optionally packagedbefore sterilization. Thus, in one example, a secondary packagingconfiguration is employed comprising shipper boxes arranged so that eachpackaged dispenser is in a single layer so as to complement thelow-penetration properties of e-beam radiation and avoid a multi-layeredpackaged device system would otherwise require a higher maximum dosageto obtain the requisite sterility than the envisioned single-layeredpackaging. Reducing the maximum dose of radiation for productsterilization reduces radiation damage to components, e.g., valve member136 of container 120.

The devices and assemblies presently described provide for aconfiguration and function that is advantageous for a person in need ofnumbing an injection site prior to self-injection, for pediatrics, orfor example, injections in proximity to the buttocks or other locationssuch as the lower legs, back, shoulders, etc.

As such, in this way, the present disclosure provides an effective wayof dispensing a vapocoolant onto the skin of a patient, e.g., that wouldbenefit from the anesthetic effect of a vapocoolant and/or where amedical treatment is to take place that would benefit from theanesthetic effect of a vapocoolant, so that an injection or otherinvasive procedure is painless or less painful. The present disclosureis not limited for use in association with injections for aestheticenhancement. Rather, it may be used in combination with any invasiveprocedure and/or with other medical devices, or for use with aninjector, catheter, inserter, or other medical device that is invasiveand likely to result in pain to the patient.

1-10. (canceled)
 11. A sterilizable vapocoolant dispenser, comprising: acontainer comprising vapocoolant, the container having a valve memberconfigured to release the vapocoolant; a housing having a distal openend; a proximal open end sized to the container; a bottom cover sealingthe proximal open end of the container; a lid sealing the distal openend; and a nozzle receiving member positioned in the housing andconfigured to engage the valve member for releasing the vapocoolant;wherein the container and its contents sterilized.
 12. The sterilizablevapocoolant dispenser of claim 11, wherein the housing has an inward andoutward tapered portion between the distal open end and the proximalopen end for receiving fingers of a human hand.
 13. The sterilizablevapocoolant dispenser of claim 11, wherein the container is fixedlypositioned in the housing.
 14. The sterilizable vapocoolant dispenser ofclaim 11, wherein the lid is irreversibly sealed to the distal open end.15. The sterilizable vapocoolant dispenser of claim 11, wherein thebottom cover is releasably coupled to the proximal open end.
 16. Asterilized vapocoolant dispenser, comprising: a container comprisingsterilized vapocoolant, the container having a valve member configuredto release the vapocoolant; a housing having a distal open end; aproximal open end sized to receive the container; and; a bottom coversealing the proximal open end-of the container; a lid sealing the distalopen end; and a nozzle receiving member positioned in the housing andconfigured to engage the valve member for releasing the vapocoolant;wherein the container and vapocoolant are sterilized.
 17. Thesterilizable vapocoolant dispenser of claim 16, wherein the container isfixedly positioned in the housing.
 18. The sterilizable vapocoolantdispenser of claim 16, wherein the lid is irreversibly sealed to thedistal open end.
 19. The sterilizable vapocoolant dispenser of claim 16,wherein the bottom cover is releasably coupled to the proximal open end.20. A method of manufacturing a sterilized vapocoolant dispenser, themethod comprising: introducing a container containing vapocoolant to ahousing, the housing comprising a distal open end, and a proximal openend sized to receive the container; sealing the proximal open end andthe remainder portion of the container with a releasably sealed bottomcover; sealing the distal open end with an irreversibly sealed lid; andsterilizing the vapocoolant and housing simultaneously.